Name: Predicase
Price: 199 USD

K-number	K213440
Device name	Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Applicant	Luliang Hongruida Health Protection Technology Co., Ltd.
Product code	LZA
Device class	Class I
Decision date	Feb 18, 2022
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs

Everything you need for a 510(k) submission. Nothing you don't.